The invention relates generally to medical devices, and in particular to implants and methods for treating various pelvic dysfunctions including procedures to repair uterine prolapse, cystoceles, rectoceles, and vaginal vault prolapse.
A vaginal prolapse can be due to age or other factors and typically results in one of three types of prolapse: hysterocele, cystocele, and rectocele. A hysterocele occurs when the uterus descends into the vagina and is often treated with a hysterectomy followed by a vaginal vault suspension. A cystocele prolapse occurs when the bladder bulges or descends into the vagina and a rectocele occurs when the rectum bulges or descends into the vagina. It is often common for more than one of a hysterocele and cystocele, a hysterocele and a rectocele to occur at the same time. Treatment of vaginal vault prolapse, including a vaginal prolapse due to a hysterocele, can include a suturing procedure or the use of an implant for support or suspension.
Another procedure to treat a prolapse caused by a hysterocele is to perform a hysterectomy. Many patients, however, want to avoid a hysterectomy for a variety of reasons, including plans for future childbearing, concern about the invasiveness of the procedure, the difficulty of the recuperation, or fear of diminished sexual function. Some women are simply reluctant to “give up” this part of their body so closely associated with their reproductive health, childbearing, and femininity.
Uterine prolapse can be effectively treated without hysterectomy, with low morbidity and high rates of patient satisfaction. A properly performed uterine suspension procedure often results in a significantly better anatomic outcome than a hysterectomy. Yet, many hysterectomy procedures are performed for pelvic prolapse. Many patients remain unaware of uterine-sparing options because with the exception of a few dedicated sub-specialists, most surgeons receive no training in these techniques. In addition, known techniques can be difficult, and can require specialized training that many general practitioners have not undertaken.
Thus a need exists for an improved apparatus and method for providing minimally invasive procedures for repair of various pelvic dysfunctions, including uterine prolapses or hysteroceles, cystoceles, rectoceles and vaginal vault prolapse.
Some known implantation methods, suffer several disadvantages. Generally, the person performing the implantation removes the implant from any protective packaging before beginning the implantation process. Implants are often implanted free-hand (i.e., without guiding apparatuses), which can increase the risk of improper implantation. Implants are generally flexible and may be difficult for a single person to orient and manage during implantation. Additionally, implants often include sutures or straps that may become tangled during implantation. Finally, some implants can become damaged during the implantation procedure. Thus, a need also exists for improved implant dispensers and methods.
A pelvic floor repair graft can be used to repair uterine prolapse, cystoceles, rectoceles, vaginal vault prolapse, and/or utero-vaginal prolapse. A urinary incontinence sling may be used to treat urinary incontinence caused by hypermobility and/or intrinsic sphincter deficiency (ISD). Hypermobility occurs when the normal pelvic floor muscles can no longer provide the necessary support to the urethra and bladder neck. As a result, the bladder neck is free to drop when any downward pressure is applied and thus, involuntary leakage occurs. ISD may be caused by the weakening of the urethral sphincter muscles or closing mechanism. As a result of this weakening, the sphincter does not function normally regardless of the position of the bladder neck or urethra. A urinary incontinence sling can be fixed to body tissue to reconstitute the support for the urethra and/or bladder and treat hypermobility and/or ISD.
Known implant assemblies can include tissue anchors. Pelvic floor repair grafts and urinary incontinence slings, for example, can be held in place by tissue anchors and/or sutures. Tissue anchors are inserted into the tissue surrounding the area where the implant is disposed. Tissue anchors, however, can be inflexible and difficult to place. Sutures can be used to suture the implant to the tissue surrounding the area where the implant is disposed. The ends of the suture, however, must be tied or otherwise reconnected to the implant once the suture is positioned around and/or through the surrounding tissue. This can make it difficult to place the suture.
Thus, a need also exists for an implant that can be easily placed and retained within a body of a patient. Specifically, a need exists for improved pelvic floor repair grafts and urinary incontinence slings.